BRAINTREE, Mass.--(BUSINESS WIRE)--Paragonix Technologies, Inc. today announced it has received ISO 13485:2003 Registration and Certification for its quality management system for the design, development and manufacturing of the Paragonix Sherpa Organ Storage and Transport Systems. ISO 13485 Certification is a necessary step towards gaining European pre-market clearance for the Paragonix Sherpa Organ Storage and Transport Systems following future review of a technical file submission by the BSI Management Systems America, Inc. (BSI). The European pre-market clearance completes the Conformité Européenne (CE), or European Conformity registration process.
William Edelman, Chairman & CEO for Paragonix commented, “ISO 13485:2003 Certification represents our first step towards gaining CE pre-market clearance in Europe for the Paragonix Sherpa Organ Storage and Transport Systems portfolio. Following the clearance of three 510(k) pre-market submissions of Sherpa Pak products for donor heart and kidney preservation1,2,3,4 by the Food and Drug Administration (FDA), and the recent submission of two additional 510(k) FDA Pre-Market Notification5, the ISO 13485 Certification is part of our strategy towards expanding commercial availability of the Paragonix Sherpa Organ Storage and Transport Systems outside the U.S.“
Paragonix previously announced on Nov 3, 2014, Filing of two 510(k) FDA Pre-Market Notifications to combine the Paragonix Sherpa Pak Cardiac and Kidney Transport Systems with any effective organ preservation solution currently marketed under 510(k) Pre-market Clearance.
Paragonix previously announced on Oct 27, 2014, Joining of David D’Alessandro, MD, as Medical Director for Paragonix.
Paragonix previously announced on July 14, 2014, Filing of a 510(k) Pre-market Notification with the US Food and Drug Administration for the Paragonix Sherpa Perfusion™ Cardiac Transport System.
Paragonix previously announced on May 28, 2014, clearance of a 510(k) Pre-Marketing Notification by the US Food and Drug Administration for the Paragonix Sherpa™ Pak Kidney Transport System Paragonix previously announced on February 24, 2014, clearance of a second 510(k) Premarket Notification by the US Food and Drug Administration for the Paragonix Sherpa™ Cardiac Transport System.
Paragonix previously announced on January 27, 2014, a presentation discussing the Sherpa Perfusion™ Cardiac Transport System during the 2014 Cutting Edge of Transplantation Meeting.
About the Paragonix Sherpa™ Portfolio of Organ Transport Technologies
Currently, the availability of organs for transplantation is governed by the “ischemic time”, which is the elapsed time from organ donation to recipient implantation. The Paragonix Sherpa™ is designed for use in conjunction with any of currently available organ preservation solutions. Paragonix Sherpa™ is fully disposable, eliminating problems associated with maintenance, device transport and contamination. Paragonix Sherpa™ is intended to provide a safe, consistent method for cold ischemic storage and transport of donor organs to recipients for implantation. The Sherpa Pak™ CTS is intended for transport of hearts and the Sherpa Pak™ Kidney Transport System is intended for transport of kidneys within the time frame currently considered as routine medical practice. The Sherpa Perfusion™ CTS is intended to be used for hypothermic oxygenated perfusion preservation of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart.
About Paragonix Technologies, Inc.
Based in Braintree, Massachusetts, and founded in 2010, Paragonix Technologies Inc., is a privately held medical device company innovating the Paragonix Sherpa™, a novel, single-use organ preservation device. Paragonix has exclusively licensed University of Texas Health Science Center San Antonio intellectual property from the Office of Technology Transfer and Commercialization. Paragonix has established a pipeline of donor organ transport devices that addresses the current donor organ shortage by maximizing donor organ utilization and improving donor organ quality throughout the entire United States.
|1 Patents issued and pending.|
|2 On February 6, 2013, Paragonix received FDA clearance of a 510(k) Pre-Market Notification for the Paragonix Sherpa Pak™ Cardiac Transport System|
|3 On February 24, 2014, Paragonix received FDA clearance of a second 510(k) Pre-Market Notification for the Paragonix Sherpa™ Cardiac Transport System|
|4 On May 28, 2014, Paragonix received FDA clearance of a 510(k) Pre-Marketing Notification by the US Food and Drug Administration for the Paragonix Sherpa™ Pak Kidney Transport System|
|5 Two 510(k) FDA Pre-Market submissions were made on November 3, 2014|